Patient Eligibility and Use of Biologics in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis in the United States

Patient Eligibility and Use of Biologics in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis in the United States

A572 VA L U E I N H E A LT H 1 6 ( 2 0 1 3 ) A 3 2 3 – A 6 3 6 differed between those in remission vs. those who were not: Tender Joint Count: 2.3...

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A572

VA L U E I N H E A LT H 1 6 ( 2 0 1 3 ) A 3 2 3 – A 6 3 6

differed between those in remission vs. those who were not: Tender Joint Count: 2.3-vs-6.1, Swollen Joint Count: 1.2-vs-4.2, 100mm VAS score: 18.6-vs-42.8, HAQ: 0.7-vs-1.6 and DAS28: 2.6-vs-4.4.  Conclusions: More than half of the patients were not in remission in this diverse cohort of RA patients in 5-EU and they experienced disproportionate level of disease burden. As the line of treatment increased, proportion of individuals achieving remission decreased. These observed patterns warrant further scrutiny to determine the best practices and improve remission rates, thereby alleviating patient burden. PMS95 Comparison of Clinical Characteristics of Patients with Rheumatoid Arthritis Receiving Their First Biologic in Europe Union and the United States Narayanan S 1, Baskett A 2, Lu Y 2, Hutchings R 2 Healthcare, Gaithersburg, MD, USA, 2Ipsos Healthcare, London, UK .

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1Ipsos

Objectives: To assess the clinical characteristics of patients with RA receiving their first biologic in EU and the US.  Methods: A multi-country medical chart-review study of RA patients was conducted among physicians (majority: rheumatologists) in hospitals and private practices to collect de-identified data on patients who were recently treated with a biologic as part of usual care. Physicians from UK, Germany, France, Italy and Spain (5EU) and the US were screened for duration of practice and patient volume and recruited from a large panel to be geographically representative in each country. Eligible RA patient charts (> 5) were randomly selected from a sample of prospective patients visiting each center/practice during the screening period. Physicians abstracted patient diagnosis, treatment patterns/dynamics and patient symptomatology/disease status.  Results: In 4Q2012, 434 physicians (5EU:337; US:97) abstracted 2085 (5EU:1534; US:551) eligible RA patient charts; current biologic patterns (5EU/US) were: 1st line (78%/69%), 2nd line (16%/21%) & 3rd+ line (6%/11%). 1577 (5EU:1199; US: 378) patients were on their first biologic. Mean age – 5EU:50.8yrs, US:52.8yrs; female – 5EU:73%; US:73%. Mean time-to-1st biologic (5EU/US) from diagnosis was 40/28 months; mean time on current 1st biologic (5EU/ US) was 24/34 months. Top-3 biologic treatments observed were – etanercept (5EU/ US:37%/42%), adalimumab (5EU/US:34%/32%), and infliximab (5EU/US:8%/10%). The top-5 reasons for biologic treatment initiation were the same across 5EU/US (‘mechanism of action’, ‘improve signs/symptoms’, ‘prevent structural damage’, ‘positive personal experience’, ‘inhibits disease progression’). Key lab measures documented were (5EU/US): ESR (22.7/24.2mm/h) and CRP (10.9/2.5mg/dl). Current disease severity per physician judgment (mild:moderate:severe) were: 5EU57%:37%:6%, US-67%:29%:3%. Among patients with available data, current HAQ (5EU:1.2/US:0.7), DAS28 (5EU:3.4/US:2.5), 100mmVAS (5EU:3.5/US:2.3), Swollen Joint Count (SWC) (5EU:2.6/US:2.0) and Tender Joint Count (TJC) (5EU:3.9/US:2.8) differed within between 5EU and US.  Conclusions: Among RA patients receiving their first biologic, disease severity differed between 5EU and US, with patients in 5EU with relatively higher burden. PMS96 Patient Eligibility and Use of Biologics in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis in the United States Narayanan S 1, Baskett A 2, Lu Y 2, Hutchings R 2 Healthcare, Gaithersburg, MD, USA, 2Ipsos Healthcare, London, UK .

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1Ipsos

Objectives: To evaluate physician assessment of patient eligibility and eventual use of biologics in RA, AS, and PsA in the US.  Methods: A multi-country cross-sectional survey of physicians (primarily rheumatologists) was conducted in the US. Physicians were screened for biologic patient volume (> 2RA biologic patients/week, > 5AS biologic patients/month, > 5PsA biologic patients/month) and recruited from a large physician-panel to be geographically representative. Practice characteristics, patient-volume, physician perceptions and practice patterns were assessed; physicians’ target patient population was grouped into 2 categories, based on physician input: Group1 – patients perceived to be eligible for biologics, Group2 – patients who ended up receiving biologics within Group1. Summary statistics across the US are reported.  Results: In 4Q2012, 97 physicians participated in the study. Mean age: 47.6yrs; female: 30%. Main practice: private office (non-hospital):46%. Patient volume per physician was: total-1904, RA-419, AS-82, PsA-145. Average frequency of patient encounters were (RA/AS/PsA; weeks): 11/12/11. Physician judgment of patient disease severity were (average across their patients): RA – mild:28%/moderate:47%/severe:25%, AS – mild:31%/moderate:43%/ severe:26% and PsA – mild:30%/moderate:44%/severe:27%. Physician assessment of patient eligibility and use of biologics were: within RA-mild-patients – Group1:21%/Group2:14%, within RA-moderate-patients – Group1:63%/Group2:51%, within RA-severe-patients – Group1:81%/Group2:70%; within AS-mild-patients – Group1:32%/Group2:24%, within AS-moderate-patients – Group1:66%/Group2:55%, within AS-severe-patients – Group1:79%/Group2:69%; within PsA-mild-patients – Group1:30%/Group2:23%, within PsA-moderate-patients – Group1:66%/Group2:55%, within PsA-severe-patients – Group1:81%/Group2:71%. Among the top-3 biologic treatments used, etanercept, adalimumab, and infliximab were observed throughout RA, AS and PsA.  Conclusions: Across the markets, between 30-45% of biologic eligible patients (per physician perception) within moderate/severe disease severity groups did not end up receiving a biologic therapy across RA/AS/PsA cohorts. Reasons behind these patterns and the impact on subsequent patient outcomes warrant further scrutiny. PMS97 Disease Burden Among Patients with Psoriatic Arthritis Who Have Experienced First Line Tumor Necrosis Factor Inhibitor Regimen Failure in the European Union Narayanan S 1, Lu Y 2, Hutchings R 2, Baskett A 2 Healthcare, Gaithersburg, MD, USA, 2Ipsos Healthcare, London, UK .

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1Ipsos

Objectives: To assess treatment patterns and disease burden among PsA patients on 2nd-line biologics after 1st-line anti-TNF failure.  Methods: A multi-country

chart-review study of PsA patients was conducted among physicians in hospitals/ private practices to collect de-identified data on patients recently treated with a biologic as part of usual care. Physicians from UK/Germany/France/Italy/Spain (5EU) were screened for practice-duration and patient-volume and recruited from a large panel to be geographically representative in each country. Eligible patient charts (> 2) were randomly selected from a sample of prospective patients visiting each center/ practice during the screening period. Physicians abstracted patient diagnosis, treatment patterns/dynamics and patient symptomatology/disease status.  Results: Between Jan2011-Dec2012, 454 PsA patients (mean age:48.8yrs;female:49.6%) on 2nd-line biologic after 1st-line anti-TNF failure were identified. Mean time-to-1stline anti-TNF from diagnosis was 51.6months; mean time on 1st-line anti-TNF was 18.3months (patients < 6/7-12/13-24/> 24months:33%/21%/19%/27%). Top-3 1st line anti-TNFs observed were: etanercept(38%), adalimumab(32%), and infliximab(27%). The top-5 reasons for 1st-line anti-TNF discontinuation were ‘long-term efficacy failure’, ‘disease worsened’, ‘side-effects not tolerated’, ‘insufficient-improvement’, and ‘initial failure of efficacy’. Mean time on current 2nd-line biologic was 18.5months (patients < 6/7-12/13-24/> 24months:28%/21%/25%/27%). Current 2ndline biologics (top-5) included: adalimumab(39%)/etanercept(31%)/infliximab(14%)/ golimumab(11%)/abatacept(2%). Top-5 reasons for choice of 2nd-line biologic were ‘mechanism of action’, ‘prevention of structural damage’, ‘improve signs/symptoms’, ‘disease worsened’, ‘positive personal experience’. Key lab measures documented were: ESR-21.7mm/h and CRP-8.3mg/dl. Among patients with available data, current HAQ was 1.1, Swollen Joint Count was 1.9 and Tender Joint Count was 3.4. Current disease severity per physician judgment (mild:moderate:severe) were: 48%:47%:5%. Current disease severity (mild:moderate:severe) by time on 1stline anti-TNF biologic (< 6/7-12/13-24/> 24months) were 47%:48%:5% / 55%:42%:3% / 49%:48%:4% / 44%:49%:7% respectively.  Conclusions: Among PsA pts on their 2nd biologic who experienced anti-TNF failure, 54% discontinued their 1st line anti-TNF regimen within 12months of initiation and continue to have considerable disease burden despite current 2nd line biologic. PMS98 Economic Impact Associated with a Biological Therapy Prioritization Protocol in Rheumatoid Arthritis Patients in the Hospital of Sagunto Borrás-Blasco J 1, Gracia-Pérez A 1, Castera D E 1, Rosique J D 1, Abad F J 1, González Álvarez A2 1Hospital de Sagunto, Sagunto, Spain, 2Hospital Obispo Polanco, Teruel, Spain .

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Objectives: Until 2010 the cost of biological treatments in Rheumatoid Arthritis (RA) was increased annually by 15% in our hospital. In 1stJanuary 2011, a Hospital Commission and Protocol of Biological Therapies were created to improve the cost-effectiveness usage of biological drugs in RA. To evaluate the economic impact associated with a biological therapy prioritization Protocol for RA patients in the Hospital of Sagunto.  Methods: Observational, ambispective study comparing the associated cost of biotreated RA patients pre-protocol (2009-2010) versus post-protocol periods (2011-2012). Inclusion criteria: RA patients treated with Abatacept (ABA) Adalimumab (ADA), Etanercept (ETN) or Infliximab (IFX) for at least 6 months during the study period (2009-2012). ETN was selected as 1st line therapy because our successful experience of ETN 25 mg/weekly in certain RA patients, its subcutaneous administration and lowest theoretical cost per patient in Spain. Cost savings and economic impact were calculated using Spanish official prices.  Results: In the pre-protocol period (2009-2010), total expenses were increased by 110,000€ , up to 1,761,000€  in 2010 (11,362€  pat/year). After protocol implementation, total expenses decreased by 53,676€  on the 2010-2011 period, and 149,200€  on the 2011-2012 period. On the 2010-2011 period the cost of biological therapy per patient-year decreased 355€  (11,007€  pat/year) and additional 653€  (up to 10,354€  pat/year) by 2012, with a cumulative effect of the protocol implementation of 1,008€  per patient-year. In the pre-protocol period, the annual cost/patient was 10.812€  with ETN, 10.942€  with IFX, 12.961€  with ADA and 12.739€  with ABA. By 1st Jan 2013, the annual cost per patient was 9,469€  with ETN, 10,579€  with IFX, 11,117€  with ADA and 13,540€  with ABA.  Conclusions: The creation of our Commission of Biological Therapies is key to rational management of RA patients and optimization of resources, allowing us to save 200,000€  after 2-year efficiency protocol implementation. PMS99 Real World Utilization of Biological Agents in Rheumatoid Arthritis Patients: A French National Claims Database Analysis Over the Period 2009-2011 Fautrel B 1, Laurendeau C 2, Joubert J M 3, Cukierman G 3, Gourmelen J 4, Fagnani F 2 1CHU Pitié-Salpétrière, Paris, France, 2Cemka-Eval, Bourg la Reine, France, 3UCB Pharma, Colombes, France, 4INSERM, Villejuif, France .

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Objectives: To describe the current medical management of Rheumatoid Arthritis (RA) patients in routine practice in a national representative sample of patients, focusing on biological agents (BA) uptake.  Methods: The EGB database is a 1/97 representative sample of the national claims database covering the whole French population. RA patients were identified as adults (age > 18) benefiting from full coverage (“ALD” eligibility criteria) for RA (ICD-10 codes M05-06) on January 1, 2009. Patients treated by BA were defined as RA patients with at least one claim for at least one BA over the period. BA-naïve treated patients were identified by the absence of a BA claim during the first 3 months of the study period, followed by at least one BA claim.  Results: Over the 3-year period, 236 patients had a BA reimbursed and 5,336 deliveries by pharmacists were observed. The proportion of BA users, either alone or in combination, was 14.0% in 2009, and 70 patients (32.7%) used a BA in combination with methotrexate. Among patients treated by BA, 85.2% used at least one TNF inhibitor during the study period. Etanercept had the highest delivery record (58.1%), followed by adalimumab (28.8%) and infliximab (15.3%). Among the whole group of patients treated by BA, 13.6% were delivered rituximab at least once. Over the period, a proportion of 73.3% of patients had one BA agent only, 19.1% experienced one switch and 7.6% had two or more switches.